510(k) · Cleared
ClearedNHAC 16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lmt Medical Systems GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 26, 2017 as substantially equivalent to K091047 (Lmt Medical Systems GmbH, 2010) after a 63-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jul 26, 2017
- Review
- 63 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934396 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK934396 Quadrature Lower Extremity CoilMedical Advances, Inc. · 1993
- 2 generations backK023929 Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003
- 1 generation backK091047 Neonate Array CoilsLmt Medical Systems GmbH · 2010
- This deviceK171515 NHAC 16Lmt Medical Systems GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934396 | Quadrature Lower Extremity Coil | Medical Advances, Inc. | 1993 | — |
| −2 | K023929 | Magnetic Resonance Diagnostic Device | Advanced Imaging Research, Inc. | 2003 | — |
| −1 | K091047 | Neonate Array Coils | Lmt Medical Systems GmbH | 2010 | — |
| 0 (this device) | K171515 | NHAC 16 | Lmt Medical Systems GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091047 | Neonate Array CoilsSummary page 4…Class: II III. PREDICATE DEVICE Manufacturer: LMT Medical Systems GmbH Device name: Neonate Array Coils 510(k) Number: K091047 IV. DEVICE DESCRIPTION AND INTENDED USE Indications for Use: The NHAC 16 is a local coil (receive only) and is… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171515: NHAC 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026